Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter Pylori, Probiotics, Eradication treatment of H.Pylori, Antibiotics, Proton pump inhibitors, Saccharomyces boulardii, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum
Brief summary
All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well. The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Detailed description
Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well. The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule). Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting). All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.
Interventions
DRUGCaps Lactolevure
One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.
DRUGCaps Placebo
Caps Placebo
Sponsors
Evangelismos Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Established Helicobacter Pylori Infection
Exclusion criteria
* Pregnancy * Lactate * Previous eradication therapy for HP. * Course of antibiotics and/or probiotics one month prior to stydy entry * Course of PPI's, H2- antagonst and antacids two weeks prior to study entry * Known allergy to antibiotics that will be used in study * Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of antibiotic side effects | Through study completion, an average of 1 year | Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale. |
Countries
Greece
Outcome results
None listed